U.S. patent application number 14/013445 was filed with the patent office on 2013-12-26 for introducer tactile feature.
This patent application is currently assigned to Cook Incorporated. The applicant listed for this patent is Cook Incorporated. Invention is credited to Bruce Fleck, Mark R. Frye, James J. Kennedy, III.
Application Number | 20130345660 14/013445 |
Document ID | / |
Family ID | 36119616 |
Filed Date | 2013-12-26 |
United States Patent
Application |
20130345660 |
Kind Code |
A1 |
Kennedy, III; James J. ; et
al. |
December 26, 2013 |
INTRODUCER TACTILE FEATURE
Abstract
An introduction system and method of use is provided. The
introduction system includes a catheter assembly, a member, and a
tactile indicator. The member is configured to be introduced
through the catheter assembly and the tactile indicator is
configured to provide a tactile sensory input when the member
reaches a predetermined position relative to the catheter assembly.
As such, the tactile indicator provides increased resistance to the
relative motion between the member and catheter assembly when the
member reaches the predetermined position.
Inventors: |
Kennedy, III; James J.;
(Deerfield, NH) ; Frye; Mark R.; (Bloomington,
IN) ; Fleck; Bruce; (Anthem, AZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cook Incorporated |
Bloomington |
IN |
US |
|
|
Assignee: |
Cook Incorporated
Bloomington
IN
|
Family ID: |
36119616 |
Appl. No.: |
14/013445 |
Filed: |
August 29, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11320041 |
Dec 28, 2005 |
|
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14013445 |
|
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|
|
60640121 |
Dec 29, 2004 |
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Current U.S.
Class: |
604/500 ;
604/528 |
Current CPC
Class: |
A61M 25/09 20130101;
A61F 2250/0039 20130101; A61F 2/958 20130101; A61M 2025/006
20130101; A61M 2025/0008 20130101; A61M 25/0102 20130101 |
Class at
Publication: |
604/500 ;
604/528 |
International
Class: |
A61M 25/01 20060101
A61M025/01 |
Claims
1. An introduction system for a medical device, the introduction
system comprising: a catheter assembly; a member to be introduced
through the catheter assembly; and a tactile indicator configured
to provide a tactile sensory input when the member reaches a
predetermined position relative to the catheter assembly.
2. The introduction system according to claim 1, wherein the
tactile indicator provides increased resistance to a relative
motion between the member and the catheter assembly when the member
reaches the predetermined position.
3. The introduction system according to claim 1, wherein the
tactile indicator mechanically interferes with the catheter
assembly to provide the tactile sensory input.
4. The introduction system according to claim 1, wherein the
tactile indicator comprises a protrusion extending from the
member.
5. The introduction system according to claim 4, wherein the
tactile indicator comprises a bead attached to the member.
6. The introduction system according to claim 4, wherein the
protrusion has rounded edges.
7. The introduction system according to claim 4, wherein the
protrusion has a generally teardrop shape.
8. The introduction system according to claim 4, wherein the
protrusion includes a first surface forming an angle greater than
45.degree. with the member.
9. The introduction system according to claim 8, wherein the
protrusion includes a second surface forming an angle about
45.degree. or less with respect to the member.
10. The introduction system according to claim 1, wherein the
catheter assembly includes a sealing adapter.
11. The introduction system according to claim 10, wherein the
tactile indicator mechanically interferes with the sealing
adapter.
12. The introduction system according to claim 1, wherein the
tactile indicator includes a textured portion of the member.
13. The introduction system according to claim 12, wherein the
textured portion has an increased surface roughness.
14. The introduction system according to claim 12, wherein the
member includes a coating and the coating has been omitted from the
textured portion.
15. The introduction system according to claim 1, wherein the
tactile indicator is one of a plurality of tactile indicators.
16. The introduction system according to claim 15, wherein the
tactile indicator provides a differentiating resistance profile
with respect to the plurality of tactile indicators.
17. The introduction system according to claim 15, wherein the
frequency of the plurality of tactile indicators is varied
longitudinally along the member.
18. The introduction system according to claim 15, wherein the
frequency of the plurality of tactile indicators is constant.
19. The introduction system according to claim 1, wherein the
catheter assembly includes a catheter and the tactile indicator
includes a narrowed portion of the catheter configured to interfere
with the member.
20. The introduction system according to claim 19, wherein the
member includes a protrusion that interferes with the narrowed
portion.
21. The introduction system according to claim 1, wherein the
tactile indicator includes a protrusion extending from the member,
the protrusion having a distal surface and a proximal surface, and
the protrusion including a recess between the proximal and distal
surface.
22. The introduction system according to claim 21, wherein the
recess is configured to bias the member in both a distal and
proximal direction toward the predetermined location.
23. A method of providing a tactile sensory input to the user of an
introduction system, the method comprising: introducing a member
through a catheter assembly; advancing the member causing a
relative motion between the member and the catheter assembly;
increasing a resistance to the relative motion using a tactile
indicator to sense a predetermined position of the member relative
to the catheter assembly.
24. The method according to claim 23, wherein the tactile indicator
mechanically interferes with the catheter assembly to provide the
tactile sensory input.
25. The method according to claim 23, wherein the tactile indicator
comprises a protrusion extending from the member.
Description
RELATED APPLICATIONS
[0001] The present patent document is a continuation of U.S.
application Ser. No. 11/320,041, filed Dec. 28, 2005, which claims
the benefit of the filing date under 35 U.S.C. .sctn.119(e) of
Provisional U.S. Patent Application Ser. No. 60/640,121, filed Dec.
29, 2004. All of the foregoing applications are hereby incorporated
by reference.
BACKGROUND
[0002] 1. Field of the Invention
[0003] The present invention generally relates to an introduction
system and method to provide sensory input to a user while
introducing a medical device.
[0004] 2. Description of Related Art
[0005] Medical devices are typically delivered to the patient
through an introduction system. The introduction system typically
includes a pre-delivered catheter used to guide the medical device
to a region of interest. Often the introduction system will include
a sealing adapter to restrict fluid flow from the catheter where
the medical device enters the catheter assembly. The user of an
introduction system often advances the medical device distally into
the patient a predetermined distance through the introduction
system. Since the user manually advances the medical device through
the introduction system, it is difficult for the user to inherently
gauge the distance that the medical device has been advanced.
Currently, some introduction systems provide a visual indicator
near the proximal end of the introduction system to indicate when
the medical device has been advanced a predetermined distance.
However, the user must redirect his attention from the patient and
any imaging device to the proximal end of the introduction system
to observe the visual indicator.
[0006] In view of the above, it is apparent that there exists a
need for an introduction system for medical device configured to
provide improved sensory input to the user.
SUMMARY
[0007] In satisfying the above need, as well as overcoming the
enumerated drawbacks and other limitations of the related art, the
present invention provides an introduction system for a medical
device configured to provide tactile sensory input to the user.
[0008] The introduction system includes a catheter assembly, a
member, and a tactile indicator. The member is configured to be
introduced through the catheter assembly and the tactile indicator
is configured to provide a tactile sensory input when the member
reaches a predetermined position relative to the catheter assembly.
As such, the tactile indicator provides increased resistance to the
relative motion between the member and catheter assembly when the
member reaches the predetermined position.
[0009] The tactile indicator may provide the increased resistance
by mechanically interfering with the catheter assembly. Further,
the tactile indicator may take the form of a protrusion extending
from the member. The protrusion may be created by a bead of solder
attached to the member, a prefabricated bead attached to the
member, or a bending or folding process that deforms an integral
portion of the member. Preferably, the protrusion has rounded edges
and may have a generally teardrop shape. Alternatively, the tactile
indicator may include a textured portion of the member. The
textured portion may have an increased tackiness or surface
roughness causing an interference or friction to provide the
tactile sensory input.
[0010] Further, the tactile indicator may be one of a plurality of
tactile indicators. In one respect, the tactile indicator may
provide a unique resistance profile with respect to the other
tactile indicators. In addition, the frequency between the
plurality of tactile indicators may be constant indicating a
predefined distance has been traveled or the frequency may be
varied along the length of the member to indicate multiple
distances or the closeness to a predetermined location.
[0011] In another aspect of the invention, the tactile indicator
may be a narrowed portion of the catheter assembly that is
configured to interfere with the member. Further, the member may
include a protrusion to enhance the mechanical interference with
the narrowed portion.
[0012] In yet another aspect of the present invention, a method for
providing sensory input is provided. The method includes
introducing a member through a catheter assembly, advancing the
member causing a relative motion between the member and the
catheter assembly, and increasing a resistance to the relative
motion using a tactile indicator to sense a predetermined position
of the member relative to the catheter assembly.
[0013] Further objects, features and advantages of this invention
will become readily apparent to persons skilled in the art after a
review of the following description, with reference to the drawings
and claims that are appended to and form a part of this
specification.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a breakaway side view of an introduction system
having a tactile indicator in accordance with one embodiment of the
present invention;
[0015] FIG. 2 is a breakaway side view of an introduction system
having a tactile indicator attached to an introducer catheter;
[0016] FIG. 3A-3E are side views of tactile indicators having
varying profiles in accordance with present invention;
[0017] FIG. 4 is a breakaway side view of an introduction system
having multiple tactile indicators in accordance with one
embodiment of the present invention; and
[0018] FIG. 5 is a flow chart of a method for using an introduction
system in accordance with the present invention.
DETAILED DESCRIPTION
[0019] Referring now to FIG. 1, a system embodying the principles
of the present invention is illustrated therein and designated at
10. As its primary components, the system 10 includes a catheter
assembly 12, a member 14 to be inserted through the catheter
assembly 12, and a tactile indicator 16.
[0020] The member 14 is shown as an introducer cannula and is
inserted into the catheter assembly 12 through a sealing adapter
18. The member 14 is advanced beyond the sealing adapter 18 and
through a catheter 20 to a region of interest within the patient.
The member 14 includes a tactile indicator 16 shown as a
protrusion. The protrusion may be formed by attaching a material to
the outer portion of the member 14 at a predetermined position. For
example, the member 14 can be made of a solderable material and a
bead of silver solder may be applied to the surface of the member
14, thereby forming the tactile indicator 16. Further, a
prefabricated bead may be machined or molded and attached to the
member 14 via solder, adhesive, or other common attachment means.
Alternatively, the member 14 may have a protrusion integrally
formed with the member through a bending or forming process.
[0021] The sealing adapter may be a Check-Floe type adapter
manufactured by Cook Inc., Bloomington, Ind. The sealing adapter 18
includes a seal 24 at its proximal end. The member 14 is inserted
into the sealing adapter 18 through the seal 24. As such, the seal
24 acts to restrict fluid from flowing from the catheter assembly
12 as the member 14 is advanced into the patient. When the member
14 is advanced a predetermined distance, a tactile sensory input
will be delivered to the user through their fingers. As such, the
user will be allowed to maintain focus on the patient or a
noninvasive imaging device, rather than focus on a visual indicator
at the proximal end of the introduction system 10. The tactile
indicator 16 creates a temporary mechanical interference between
the member 14 and the seal 24 of the sealing adapter 18. As the
member 14 is further advanced, the seal 24 of the sealing adapter
18 will deform to allow the tactile indicator 16 to pass
therethrough. Similarly, as the member 14 is withdrawn, the tactile
indicator 16 will interfere with the seal 24 of the sealing adapter
18. Again, the user will receive tactile sensory input that the
member 14 has been withdrawn to the predefined location.
[0022] Now referring to FIG. 2, another embodiment of an introducer
system according to the present invention is provided. A member 34
is inserted into a catheter assembly 32 through a sealing adapter
40. The member 34 is advanced beyond the sealing adapter 40 and
through catheter 35 to a region of interest within the patient. The
catheter 35 may include a tactile indicator 36 shown as a narrowed
portion within the catheter 35. The narrowed portion causes a
mechanical interference with the member 34 providing the user a
tactile sensory input as the member 34 reaches a predetermined
location. The diameter of the member 34 may have a profile to vary
the mechanical interference and, therefore, the resistance provided
by the tactile indicator 36. The tactile indicator 36 may be formed
by a reduced diameter of the lumen within the catheter 35, or by
other means restricting catheter 35. As the member 34 passes
through the tactile indicator 36, the catheter 35 deforms allowing
the member 34 to advance along the catheter 35. Similarly, as the
member 34 is withdrawn from the catheter assembly 32, the tactile
indicator 36 will interfere with the member 34 increasing
resistance to the relative motion between the member 34 and the
catheter assembly 32. The increased resistance provides a tactile
sensory input to the user. Alternatively, the member 34 may include
a protrusion 38 to further enhance the tactile sensory input
provided to the user as the protrusion 38 passes through the
tactile indicator 36 at the predetermined location. As the
protrusion 38 passes through the tactile indicator 36, the catheter
35 deforms allowing the protrusion 38 to pass therethrough.
[0023] Now referring to FIG. 3-A, a tactile indicator 50 is shown
on a member 52, such as, an introduction cannula that may be
inserted into a sealing adapter causing a mechanical interference
with the seal and providing tactile sensory input for the user. The
tactile indicator 50 is shown as a bead attached to the member 52.
Preferably, the tactile indicator 50 has a profile that is
concentric with the member 52, although asymmetric shapes may be
readily used. A concentric profile minimizes and uniformly applies
any deformation, caused by the tactile indicator 50, across the
circumference of the seal. The tactile indicator 50 has a distal
surface 54 that is generally rounded to eliminate any sharp edges.
The generally rounded shape of the distal surface 54 prevents
damage to the seal as the tactile indicator 50 is advanced
therethrough. The slope or curvature of the distal surface 54 may
be varied to provide more or less resistance to the advancement of
member 52.
[0024] The tactile indicator 50 also includes a proximal surface 56
that serves to interfere with the seal of the sealing adapter as
the member 52 is withdrawn. The proximal surface 56 has a generally
rounded shape to prevent damage of the seal. The slope and
curvature of the proximal surface 56 may be varied to provide more
or less resistance to the withdrawal of the member 52. In addition,
the proximal surface 56 may have a different slope and curvature
than the distal surface 54 providing for a different sensory input
during advancement and withdrawal of the member 52.
[0025] Now referring to FIG. 3-B, a tactile indicator 60 is shown
on the member 62, such as, an introduction cannula that may be
introduced into a sealing adapter, causing a mechanical
interference with the seal. The mechanical interference provides a
tactile sensory input for the user. The tactile indicator 60 is
shown as a bead attached to the member 62. Preferably, the tactile
indicator 60 has a profile that is concentric with the member 62.
As such, any deformation of the seal in the sealing adapter caused
by the interference of the tactile indicator 60 with the seal will
be minimized and uniformly applied across the circumference of the
seal. The tactile indicator 60 has a generally teardrop shape, that
provides a hard bump or sudden increase in resistance upon
insertion, and provides a soft resistance upon removal. The tactile
indicator 60 has a distal surface 64 that is generally rounded such
that any sharp edges are eliminated to protect the seal during
advancement. As such, the distal surface 64 has a slope that is
greater than 45.degree. with respect to the surface of the member
62. The distal surface 64 forms the head of the teardrop shape to
cause a sudden increase in resistance as the member 62 is advanced
to the predetermined position. The proximal surface 66 has a slope
that is about 45.degree. or less with respect to the surface of
member 62 and forms the tail of the teardrop to cause a soft
resistance as the member 62 is withdrawn at the predetermined
position.
[0026] Alternatively, a teardrop shape may be used to provide soft
resistance during insertion and hard resistance during withdraw, as
shown in FIG. 3-C. The tactile indicator 70 is shown as a bead
attached to the member 72. The proximal surface 76 has a slope that
is greater than 45.degree. with respect to the surface of member 72
and forms the tail of the teardrop to cause a soft resistance as
the member 72 is advanced to the predetermined position. The distal
surface 74 has a slope that is about 45.degree. or less with
respect to the surface of the member 72 and forms the head of the
teardrop to cause a sudden increase in resistance as the member 72
is withdrawn to the predetermined position.
[0027] Now referring to FIG. 3-D, a tactile indicator 80 is shown
on the member 82, such as, an introduction cannula that may be
introduced into a sealing adapter causing a mechanical interference
with the seal and providing tactile sensory input that biases the
member 82 to the predetermined position in both a proximal and
distal direction. The tactile indicator 80 is shown as a bead
attached to the member 82. Preferably, the tactile indicator 80 has
a profile that is concentric with the member 82. As such, any
deformation of a seal in the sealing adapter, caused by the
interference of the tactile indicator 80 with the seal, will be
minimized and uniformly applied across the circumference of the
seal. The tactile indicator 80 has a distal surface 84 that is
generally rounded, such that, any sharp edges are eliminated. The
generally rounded shape of the distal surface 84 prevents damage to
the seal, as the tactile indicator 80 is advanced therethrough. The
tactile indicator 80 also includes a proximal surface 86 that
serves to interfere with the seal of the sealing adapter as the
member 82 is withdrawn. In addition, the proximal surface 86 may
have a different slope and curvature than the distal surface 84
providing for a different sensory input during advancement and
withdrawal of the member 82.
[0028] Further, a portion 87 of the tactile indicator 80 located
between proximal surface 86 in the distal surface 84 may have a
profile that varies longitudinally. As such, the portion 87 may
narrow in diameter or have a recess 88 that biases the member 82 to
the predetermined location in both a distal and proximal direction.
The recess 88 has two surfaces sloped towards each other such that
when the member 82 is in the predetermined location the seal aligns
with the recess 88. The proximal most surface of the recess 88
biases the seal distally and a distal most surface of the recess 88
biases the seal proximally. The slope of the recess 88 and the
length of the portion 87 can be determined, such that, both
surfaces of the recess 88 simultaneously engage seal.
[0029] Now referring to FIG. 3-E, a tactile indicator 90 is shown
on the member 92 such as, an introduction cannula. The tactile
indicator 90 shown as a textured portion 94 on the surface of the
member 92. The member 92 may be introduced into a sealing adapter
causing interference and friction between the seal of the sealing
adapter and the tactile indicator 90. The interference provides
tactile sensory input for the user. The textured portion 94 may
include a coating to increase the tackiness or surface roughness of
the textured portion 94 with respect to the rest of the surface of
member 92. Alternatively, a coating may be omitted from the
textured portion 94 that has been applied to the rest of the
surface of member 92 thereby increasing the tackiness or surface
roughness of the textured portion 94 relative to other portions of
member 92.
[0030] Now referring to FIG. 4, an introduction system is provided
including a catheter assembly 102, a member 104 to be inserted
through the catheter assembly 102, and a plurality of tactile
indicators 107. The member 104 is shown as an introducer cannula
and is inserted into the catheter assembly 102 through a sealing
adapter 112. The member 104 is advanced beyond the sealing adapter
112 and through a catheter 110 to a region of interest within the
patient. The member 104 includes tactile indicators 107, shown as
beads attached to the surface of the member 104. Each tactile
indicator 106, 108, 109, and 111 is located at a predetermined
position along the member 104. Further, tactile indicator 106 has a
different longitudinal profile than tactile indicator 108. For
example, tactile indicator 106 has a teardrop shape with the head
of the teardrop facing distally, while tactile indicators 108, 109,
and 111 have a teardrop shape with the head facing proximally. The
frequency between beads may also be varied. For example, a first
resistance is felt when tactile indicator 106 passes through the
seal 114. As the member 104 is advanced, the user will feel
resistances at an increased frequency as tactile indicators 108 and
109 pass through the seal 114. The increased frequency may indicate
the user is approaching a predetermined location, or may have other
preferred significance. Alternatively, the frequency of the tactile
indicators may be constant along the length of the member 114
indicating a predetermined distance has been traveled between the
tactile indicators, such as between tactile indicators 108, 109,
and 111.
[0031] The member 104 is inserted into the sealing adapter 112
through a seal 114. As such, the seal 114 acts to restrict fluid
from flowing from the catheter assembly 102 as the member 104 is
advanced into the patient. When the member 104 is advanced a
predetermined distance, a tactile sensory input will be delivered
to the user, through their fingers. The tactile indicator 106
creates a temporary mechanical interference between the head of
tactile indicator 106 and the seal 114 of the sealing adapter 112,
causing a sudden increase in resistance. As the member 104 is
further advanced, the seal 114 of the sealing adapter 112 will
deform to allow tactile indicator 106 to pass therethrough. As
tactile indicator 108 is advanced through the seal 114 the tail of
indicator 108 causes a soft resistance easily distinguishable from
tactile indicator 106. Similarly, as the member 104 is withdrawn,
the head of tactile indicator 108 will interfere with the seal 114
of the sealing adapter 112. Again the user will receive tactile
sensory input that the member 104 is being withdrawn to a
predefined location. As member 104 is withdrawn further, the tail
of tactile indicator 106 will cause a soft resistance as the seal
114 is deformed, allowing tactile indicator 106 to pass
therethrough. The opposing teardrop configuration discussed is
merely illustrative and many combinations of tactile indicator
profiles are contemplated herein.
[0032] Now referring to FIG. 5, a method is provided for generating
a tactile sensory input for the user of an introduction system. The
method includes introducing a member through a catheter assembly as
denoted by block 120. The member is advanced into the patient
causing a relative motion between the member and the catheter
assembly as denoted by block 122. As the member is advanced, a
tactile indicator is used to increase a resistance to the relative
motion when the member reaches a predetermined position relative to
the catheter assembly as denoted by block 124. The method described
herein may be implemented according to any of the variations or
embodiments described above.
[0033] As a person skilled in the art will readily appreciate, the
above description is meant as an illustration of implementation of
the principles this invention. This description is not intended to
limit the scope or application of this invention in that the
invention is susceptible to modification, variation and change,
without departing from spirit of this invention, as defined in the
following claims.
* * * * *